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| ID | Type | Description | Link |
|---|---|---|---|
| CT-2026-CTN-01536-1 | Other Identifier | Australia Therapeutic Goods Administration (TGA): |
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The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet. In addition, this study evaluates the effect of food on the absorption of sonrotoclax after administration of the tablet for oral suspension and the resulting blood levels of sonrotoclax.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonrotoclax Tablet for Oral Suspension | Experimental | Participants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonrotoclax Tablet for Oral Suspension | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax | Approximately 20 days | |
| Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax | Approximately 20 days | |
| Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax | Approximately 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax | Approximately 20 days | |
| Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax | Approximately 20 days | |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 1-877-828-5568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Early Phase | Recruiting | Joondalup | Western Australia | WA 6027 | Australia |
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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| Sonrotoclax Tablet | Drug | Administered orally |
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| Apparent Total Clearance (CL/F) for Sonrotoclax |
| Approximately 20 days |
| Apparent Volume of Distribution (Vz/F) for Sonrotoclax | Approximately 20 days |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to approximately 47 days |
| Number of Participants with Abnormal Clinically Significant Electrocardiogram (ECG) Values | Clinically significant ECG values include a prolonged QT interval, presence of atrial fibrillation or other significant arrhythmia. | Up to approximately 47 days |
| Number of Participants with Clinically Significant Vital Signs Measurements | Vital signs include pulse rate, body temperature, and blood pressure. | Up to approximately 47 days |
| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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